"Mei" Tian New Drug Announcements and Product Updates as of October 16

Oct 16, 2024 07:30 CST Updated 07:30

Apeiron

Pharmaceutical R&D Developer

Daiichi - Sankyo

Pharmaceutical Development, Production, Sales, and Consulting Service Provider

GSK China

Pharmaceutical Manufacturer

On October 14, Apeiron Therapeutics announced that the clinical trial application (IND) for its second-generation MTA-cooperative PRMT5 inhibitor, GTA182, has been approved by the NMPA, and it is planned to be developed for the treatment of MTAP-deficient solid tumors.

On October 15, the CDE website announced that the TVAX-008 injection, a Class 1 new drug developed by Nanjing Yuanda Savex Biopharmaceutical Co., Ltd., is proposed to be included in the breakthrough therapy category for the treatment of chronic hepatitis B virus (HBV) infection. TVAX-008 is a therapeutic hepatitis B vaccine developed by Yuanda Savex.

On October 14, Chia Tai Tianqing's Letemovir Injection was approved for marketing in China. This product is the first domestic generic version of the Letemovir Injection formulation in China. Letemovir is a new antiviral drug.

On October 14, the NMPA website revealed that the new lung cancer indication for trastuzumab deruxtecan for injection (Enhertu, Yuhede), filed by Daiichi Sankyo, has been approved for marketing. It is approved for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) who have HER2-activating mutations and have previously received at least one systemic therapy.

On October 15, the CDE website showed that the injectable Belantamab mafodotin submitted by GSK China is proposed to be included in the priority review, for the indication of combination treatment with bortezomib and dexamethasone in adult patients with multiple myeloma (MM) who have previously received at least one therapy.

Investment and Financing in Pharmaceuticals

On October 14, Lundbeck and Longboard Pharmaceuticals announced an agreement under which Lundbeck will acquire Longboard for approximately $2.5 billion, gaining access to its potential "best-in-class" lead program bexicaserin (LP352). The transaction is expected to be completed in the fourth quarter of 2024. According to the press release, this therapy has the potential to become a blockbuster drug, with a global phase 3 trial for the treatment of Dravet syndrome-related seizures currently underway.

Technology-Driven Drug Research

On October 9, the main issue of *Nature* published a research report from Harvard Medical School, Brigham and Women's Hospital, Boston Women’s Hospital, Dana-Farber Cancer Institute, Cedars-Sinai Medical Center (Cedars-Sinai Samuel Oschin Comprehensive Cancer Institute), and the Institute of Cancer Research, University of London. The study first discovered that the combination of AKT inhibitors and histone methyltransferase EZH2 inhibitors can kill triple-negative breast cancer by hijacking the degradation mechanism, becoming a highly promising therapeutic combination.

[1]Schade, A.E., Perurena, N., Yang, Y. et al. AKT and EZH2 inhibitors kill TNBCs by hijacking mechanisms of involution. Nature (2024). https://doi.org/10.1038/s41586-024-08031-6

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